Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Under general supervision, the Environmental Monitoring and Sampling Technicianwill perform routine procedures and sampling of environmental monitoring, watersystems, and gasesin support of Manufacturing Operations.
Responsibilities:
Perform environmental monitoringroutinesample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the sops
Will also be responsible for documenting and entering data into applicable GMP forms
Must learn and comply with safety guidelines,GLP, andcGMPs/CFRs which includes, but is not limited to, the maintenance of training records, writtenprocedures, and logbooks
Ensure timely completion of testing and tasks as assigned
Identify opportunities for continuous improvements
Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner
Assist in the implementation of new assay methodologies and the associated instrumentation
Identify and support initiation of Deviations, CAPAs, and Laboratory Investigations, as required by the client sponsorand as indicated in established procedures
Attention and dedication to quality
Demonstrated ability to deliver results in a real-time environment
Be a team player
Ability to work shift hours supporting 24/7 operations
Bachelor’s degree in SciencesORAssociate’sdegree & 4 years of directly related experienceORHigh school diploma / GED & 6 years of directly related experience
A minimum oftwo (2)years inlaboratoryexperience, preferablyin the Manufacturing/Pharmaceutical Industryis required
Experience working in acleanroom environment
Strong knowledge and understanding of GMP, regulatory requirements, written procedures,methods, and safety guidelines
Basic knowledge and experience in sampling and inspection processes for raw material, components, drug substance, drug product, and devices per procedures and regulations
Computer Software SkillsinMicrosoft Office Suite (Word, Excel, PowerPoint), SAP/ERP,eBR,LIMS, andTrackwiseamongothers.MicrosoftOffice (Word, Excel,Outlook)in a beginnerto intermediate level
Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities,tasks, and projects simultaneously
Good communication skills and presentation skills, (both written and verbal)
Organization skills and talent to perform assignments with a high degree of attention to detail
Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidaysasrequired)
Intermediate math skills with an ability to calculate with percentages and decimalsare required
The ability to understand and interpret both written and oral communication in Englishis a plus
The COVID-19 vaccine is / may be a condition of employment
Physical Requirements and Working Environment:
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings
Work in areas that may have strong magnets
May work in areas with exposuretoutility areas (vapor, gasses, high temperature, among others)
Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays)
Requireworkingin and around laboratories and controlled, enclosed, restricted areas, including clean rooms
No make-up, nail polish, and/or jewelry may be worn in the GMP process areas
Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield
Ability to wear PPE face covers for pandemics compliance when required
Ability to wear PPE and follow indications for the management of hot water samples
Current driver's License is Required
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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